# K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Jul 29, 2010 after 251 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811678 (1981). 2 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042797: Wro 300 Water Purification System for Hemodialysis, Gambro Renal Products (2005) Summary page 2.

## Most influential descendants
- K110578: Millenium HX Portable Reverse Osmosis Water Purification System (2011), 6 descendants of its own
- K124059: Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT) (2013), 5 descendants of its own
- K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF (2014), 3 descendants of its own
- K213507: AquaA (2022), 1 descendant of its own
- K171099: EON Portable Reverse Osmosis Water Purification System (2018), 1 descendant of its own

## Indications for use
The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment. WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards. The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment. WTRO 300 H can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

Source page: https://510kreport.com/device/K093608
Methodology: https://510kreport.com/methodology